What term describes a product that is similar to a biologic already approved by a regulatory agency?

The term that accurately describes a product that is similar to a biologic already approved by a regulatory agency is "biosimilar." Biosimilars are specifically designed to have no clinically meaningful differences in safety, purity, and potency compared to the reference biologic product. They provide an important option for healthcare providers and patients by increasing access to biologic therapies, as they are typically marketed at a lower price than their reference products.

In contrast, a reference product refers to the original biologic that has been approved and serves as the benchmark for assessing biosimilars. An innovative product represents a completely novel product that has not been previously authorized and is not derived from another biologic. A generic product usually pertains to small-molecule drugs that are chemically identical to a brand-name medication but does not apply to biologics due to their complex and variable nature.